Clinical Trials Logo

Clinical Trial Summary

Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action

Clinical Trial Description

A multicenter, extension study to assess long term safety and efficacy of an active implantable VNS device in adult patients with rheumatoid arthritis. The study is uncontrolled and randomized, where the sites and subjects are blinded to treatment until completion of the parent study. Subjects who were randomized to the inactive device group in the parent study are re-randomized to receive active vagus nerve stimulation either 1 min QD or 1 min QID. Subject who were randomized to the active device groups remain on their assigned treatment (1 min QD, 1 min QID). Study treatment in SPM-011 begins at the Day 0 Visit. At the Day 0, Week 1, 2, 3, 4 and 5 Visits, all subjects are given the opportunity to have the output current of their implant adjusted to the maximum level tolerated. From Week 5 onward, subjects will receive their maximally tolerated output current as 1 min QD or 1 min QID treatment. Follow up assessment visits occur at Week 8, Week 12, Months 6, 9, 12, 18, 24, 30, 33 and 36. Subjects are assessed for safety and durability of response throughout the follow up period. If the subject's symptoms or RA disease worsens, additional concomitant medications are allowed for treatment of their RA. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04862117
Study type Interventional
Source SetPoint Medical Corporation
Status Active, not recruiting
Phase N/A
Start date July 28, 2018
Completion date January 8, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Recruiting NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Recruiting NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT01087125 - Abatacept Pregnancy Exposure Registry
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Recruiting NCT03312465 - Anatomical Shoulder Domelock System Study
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4
Completed NCT01942174 - VACcination In Methotrexate Treated Rheumatoid Arthritis Patients Phase 3
Completed NCT03691909 - A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis Phase 1/Phase 2
Completed NCT02139345 - TC-A Registration Study N/A
Recruiting NCT04079920 - Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
Recruiting NCT03699293 - NSAIDs vs. Coxibs in the Presence of Aspirin Phase 4
Completed NCT02648035 - EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Enrolling by invitation NCT04060875 - Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Completed NCT02885181 - Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate Phase 2